CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) has received clearance from the U.S. Food and Drug Administration (FDA) for its second Investigational New Drug (IND) application for CER-1236, allowing the company to initiate a Phase 1 clinical trial in advanced solid tumors, specifically non-small cell lung cancer and ovarian cancer.
This milestone follows the company's earlier IND clearance for CER-1236 in acute myeloid leukemia (AML), demonstrating the potential versatility of the company's novel immunotherapy platform across both hematological malignancies and solid tumors.
"Following the launch of our AML trial, we are now starting a second clinical study of CER-1236 to evaluate its potential in solid tumors and bring new therapeutic options to patients with ovarian and lung cancer," said Robert Sikorski, M.D., Ph.D., Chief Medical Officer of CERo. "CER-1236 is novel: the first CAR-T cell therapy to target Tim-4L and the first with phagocytic activity programmed into a T cell."
Novel Mechanism of Action
CER-1236 represents a significant advancement in cellular immunotherapy by incorporating elements of both innate and adaptive immunity. The therapy employs what CERo calls Chimeric Engulfment Receptor T cells (CER-T), which are engineered to utilize phagocytic mechanisms to destroy cancer cells.
This dual-mechanism approach may help overcome key resistance barriers that have historically limited the effectiveness of CAR-T cell therapies in solid tumors. Traditional CAR-T therapies have shown remarkable success in certain blood cancers but have faced significant challenges in treating solid tumors due to issues with tumor penetration, immunosuppressive microenvironments, and antigen heterogeneity.
Dr. Sikorski emphasized that "Preclinical data suggest that this dual mechanism may help overcome key resistance barriers that have hampered solid tumor CAR-T trials."
Promising Preclinical Results
At the 2025 SITC Spring Scientific Cellular Therapy for Solid Tumors meeting in San Diego, CERo presented encouraging preclinical data for CER-1236 in ovarian cancer. The poster, titled "TIM-4-L Expression on Ovarian Cancer Samples can be Targeted by Engineered Chimeric Engulfment Receptor T cells without Toxicity," demonstrated that CER-1236 effectively treated ovarian cancer cells without generating toxicity in animal models.
Following administration of CER-1236, investigators observed T cell engraftment in lymphoid organs but found no evidence of toxicity in clinical pathology assessments or histopathological evaluations. These findings support the safety profile of CER-1236 and its potential as a treatment for solid tumors.
Dual Clinical Development Strategy
CERo is simultaneously advancing two Phase 1 clinical trials for CER-1236 – one in AML and now a second in solid tumors. This parallel development approach reflects the company's confidence in the broad therapeutic potential of its lead compound.
"Of note, our team has been simultaneously progressing our Phase 1 AML trial in the U.S. Their incredible efforts cannot be under-emphasized, and I wish to convey my gratitude to our extremely competent and efficient team," said CERo CEO Chris Ehrlich. "We are looking forward to sharing progress on each of our two Phase 1 clinical trials in the near term."
Technology Platform and Company Background
CERo's proprietary approach to T cell engineering integrates characteristics of both innate and adaptive immunity into a single therapeutic construct. This novel cellular immunotherapy platform redirects patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells.
The company believes that the differentiated activity of CER-T cells will provide greater therapeutic application than currently approved chimeric antigen receptor (CAR-T) cell therapies, potentially spanning both hematological malignancies and solid tumors.
Clinical Trial Timeline and Future Directions
With FDA clearance now secured for both indications, CERo is positioned to advance its clinical development program for CER-1236. The company anticipates that these Phase 1 trials will provide critical data on safety, tolerability, and preliminary efficacy in both hematological and solid tumor settings.
The FDA's collaborative role has been instrumental in maintaining development velocity and enabling CERo to operate two open trials simultaneously. This expansion reflects the company's belief in the therapeutic breadth and commercial potential of CER-1236.
As CERo moves forward with its clinical trials, the oncology community will be watching closely to see if this novel approach can deliver on its promise to overcome the limitations of current cellular immunotherapies and provide new treatment options for patients with difficult-to-treat cancers.
